Comparison of Two Phacoemulsification-methods: Low Fluidic EasyTip 2.2mm vs. High Fluidic EasyTip 2.2mm
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- phacoemulsification time
Study Overview
Brief Summary
The aim of this study was to compare the intraoperative efficiency, safety and postoperative outcomes of cataract surgery with two different "high-fluidic" settings.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •bilateral age-related cataract
- •good overall physical constitution
Exclusion Criteria
- •previous intraocular surgery or ocular trauma
- •previous corneal pathology
- •previous endothelial cell count <1200
- •diabetic retinopathy and any other severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely
- •intraocular complication like posterior capsular
- •postoperative comlpications (e.g. postoperative uveitis)
Arms & Interventions
HF easyTip 2.2mm
The phacoemulsifications tip used was the easyTip 2.2mm tip (Oertli Instruments, Berneck, Switzerland). The cristaline lens was divided into four quadrants using an aspiration flow rate of 10ml/min and vacuum of 70 mmHg. The quadrants were aspirated using the following linear power and fluidic settings: aspiration flow rate 45ml/min, vacuum 600 mmHg, bottle height 100cm.
Intervention: cataract surgery (Procedure)
LF easyTip 2.2mm
The phacoemulsifications tip used was the easyTip 2.2mm tip (Oertli Instruments, Berneck, Switzerland). The cristaline lens was divided into four quadrants using an aspiration flow rate of 10ml/min and vacuum of 70 mmHg. The quadrants were aspirated using the following linear power and fluidic settings: aspiration flow rate 20ml/min, vacuum 400 mmHg, bottle height 100cm.
Intervention: cataract surgery (Procedure)
Outcomes
Primary Outcomes
phacoemulsification time
Time Frame: intraoperative
time spent for the phacoemulsification process was the phacoemulsification tip time (PTT) needed to divide the nucleus and the PTT needed to conquer it
effective phacoemulsification time
Time Frame: intraoperative
time in seconds required had 100% power been used throughout the phacoemulsification process documented for the separation of the nucleus (divide) and the aspiration of the quadrants (conquer)
fluid volume
Time Frame: intraoperative
amount of BSS used for dividing and conquering
Secondary Outcomes
- postoperative corneal oedema(1 day, 1 week, 6 months)
- postoperative endotheial cell loss(6 months)
Investigators
Rupert Menapace
Ao.Univ.-Prof. Dr.med.univ.
Medical University of Vienna